Axonics Receives Regulatory Approval for Recharge-Free SNM System in Australia

Rhea-AI Summary

Axonics announced it received regulatory approval from the Therapeutic Goods Administration (TGA) in Australia for its Axonics F15™ recharge-free sacral neuromodulation (SNM) system, intended to treat adults with overactive bladder. This approval allows Australians to access a device with longer longevity, constant current stimulation, and a user-friendly remote control. The launch in Australia follows Axonics' commencement of SNM commercial activities in March 2023. Additionally, Axonics markets Bulkamid®, a hydrogel product for female stress urinary incontinence, in the region. Axonics aims to continue promoting its innovative incontinence therapies globally.

Positive

• Regulatory approval from TGA for Axonics F15™ SNM system in Australia.
• The recharge-free system offers increased device longevity and constant current stimulation.
• Axonics commenced SNM commercial activities in Australia in March 2023.
• Presence in Australia, Europe, and the United States, indicating a global market expansion.
• Markets Bulkamid® in Australia, expanding product portfolio.

Negative

• Potential increased competition in the Australian market for SNM and incontinence products.
• Financial burden of launching new products in additional markets.

Insights

Medical Device Expert

The approval of Axonics' F15 recharge-free sacral neuromodulation (SNM) system by Australia's Therapeutic Goods Administration (TGA) is a significant step for the company. This approval allows Axonics to market a product that offers a clear advantage in terms of device longevity and ease of use over existing technologies. The F15 system's recharge-free feature is particularly noteworthy as it addresses one of the common pain points for patients using SNM systems: the inconvenience of regular recharging. This can lead to higher patient satisfaction and potentially better adherence to treatment.

For investors, this milestone means Axonics is well-positioned to capture a larger market share in Australia, adding to their existing presence in the United States and Europe. The healthcare market in Australia is robust and there is a growing demand for advanced medical devices that improve quality of life. The company’s strategy to introduce innovative products shows promise for sustained growth.

Market Research Analyst

From a market perspective, the regulatory approval of Axonics’ recharge-free SNM system in Australia is a positive development. It enhances the company's product portfolio and strengthens its competitive position in the neuromodulation market. The approval could also act as a catalyst for capturing a significant market share in Australia, which is a growing market for medical devices.

Moreover, the approval may lead to increased brand recognition and trust among healthcare professionals and patients alike. This could translate into higher sales and potentially open doors for additional regulatory approvals in other countries. However, it's important to monitor how quickly Axonics can penetrate the market and whether they can scale their operations to meet the anticipated demand.

Financial Analyst

For retail investors, Axonics receiving regulatory approval for their F15 recharge-free SNM system in Australia is a key development. This approval could positively impact the company’s financial performance in the coming quarters as they expand their market reach. The F15 system’s appeal lies in its enhanced features and ease of use, which are likely to drive higher adoption rates, thereby increasing revenue streams.

In the short term, the stock may see a positive reaction due to the news. However, investors should also consider the long-term implications, such as the potential for increased research and development expenses and marketing costs associated with launching the new product. Balancing these costs against the anticipated revenue growth will be important for maintaining sustainable profitability.

IRVINE, Calif.--(BUSINESS WIRE)-- Axonics, Inc. (Nasdaq: AXNX) today announced that it has received regulatory approval from the Therapeutic Goods Administration (TGA) for marketing the Axonics F15™ recharge-free sacral neuromodulation (SNM) system in Australia to treat adults with overactive bladder.

“Approval of the Axonics recharge-free system is welcome news for Australians with bladder and bowel dysfunction,” said Dr. Ailsa Wilson Edwards, a urologist at Calvary North Adelaide Hospital. “I am excited to offer my patients a recharge-free option that significantly increases device longevity compared to legacy technology, provides constant current stimulation, and utilizes a simple remote control that is recharge-free and easy for patients to use.”

Axonics commenced SNM commercial activities in Australia in March 2023. In Australia, in addition to its SNM products, Axonics markets Bulkamid^®, the company’s unique hydrogel indicated for female stress urinary incontinence.

“We are delighted to receive regulatory approval for our latest SNM system in Australia,” said Raymond W. Cohen, chief executive officer of Axonics. “Our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, and raising awareness of our best-in-class incontinence therapies in the United States, Europe and Australia.”

About the Axonics F15 SNM system

The Axonics F15 SNM system utilizes a recharge-free implantable neurostimulator (INS) that is relatively small and thin at only 10 cubic centimeters in volume. The INS employs a primary cell battery and has an expected life in the body of over 15 years at typical stimulation parameters and over 20 years at lower energy settings. Constant current stimulation allows the device to automatically adjust the magnitude of stimulation to maintain symptom relief with minimal reprogramming. The F15 is MRI compatible with 1.5 and 3.0T whole-body MRI scanners and utilizes an intuitive, easy to use recharge-free patient remote control.

About Axonics

Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022.

Axonics^® sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid^®, provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. For more information, visit www.axonics.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words like “may,” “will,” “likely,” “should,” “expect,” “anticipate,” “future,” “plan,” “believe,” “intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,” “continue,” and variations of such words and similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, assumptions, and uncertainties, including, but not limited to, risks related to: Axonics’ ability to consummate the transactions contemplated by the Agreement and Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by and among Axonics, Boston Scientific Corporation (“Boston Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary of Boston Scientific (“Merger Sub”), providing for the merger of Merger Sub with and into Axonics with Axonics continuing as the surviving company and a wholly owned subsidiary of Boston Scientific (the “Merger”), in a timely manner or at all; the risk that the Merger Agreement may be terminated in circumstances requiring the payment by Axonics of a termination fee; the satisfaction (or waiver) of the conditions to the closing of the Merger; potential delays in consummating the Merger; the occurrence of any event, change or other circumstance or condition that could give rise to termination of the Merger Agreement; Axonics’ ability to timely and successfully realize the anticipated benefits of the Merger; the ability to successfully integrate the businesses of Axonics and Boston Scientific; the effect of the announcement or pendency of the Merger on Axonics’ current plans, business relationships, operating results and business generally; the effect of limitations placed on Axonics’ business under the Merger Agreement; significant transaction costs and unknown liabilities; litigation or regulatory actions related to the Merger Agreement or Merger; FDA or other U.S. or foreign regulatory or legal actions or changes affecting Axonics or Axonics’ industry; the results of any ongoing or future legal proceedings, including the litigation with Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”); any termination or loss of intellectual property rights, including as a result of the Medtronic Litigation; introductions and announcements of new technologies by Axonics, any commercialization partners or Axonics’ competitors, and the timing of these introductions and announcements; changes in macroeconomic and market conditions and volatility, including the risk of recession, inflation, supply chain constraints or disruptions and rising interest rates; and economic and market conditions in general and in the medical technology industry specifically, including the size and growth, if any, of Axonics’ markets, and risks related to other factors described under “Risk Factors” in other reports and statements filed with the U.S. Securities and Exchange Commission (“SEC”), including Axonics’ most recent Annual Report on Form 10-K, which is available on the investor relations section of Axonics’ website at www.axonics.com and on the SEC’s website at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements.

The forward-looking statements included in this press release are made only as of the date of this press release, and except as otherwise required by federal securities law, Axonics does not assume any obligation nor does it intend to publicly update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240516138680/en/

Axonics contact:

Neil Bhalodkar

IR@axonics.com

Source: Axonics, Inc.

FAQ

What recent approval did Axonics (AXNX) receive in Australia?

Axonics received regulatory approval from the Therapeutic Goods Administration (TGA) for its recharge-free sacral neuromodulation (SNM) system, Axonics F15™.

What is the Axonics F15™ system used for?

The Axonics F15™ system is used to treat adults with overactive bladder.

When did Axonics start commercial activities for SNM in Australia?

Axonics commenced its SNM commercial activities in Australia in March 2023.

What other product does Axonics market in Australia besides the SNM system?

Axonics also markets Bulkamid®, a hydrogel for female stress urinary incontinence, in Australia.

Who commented on the approval of the Axonics F15™ system?

Dr. Ailsa Wilson Edwards, a urologist at Calvary North Adelaide Hospital, commented on the approval.

What are the benefits of the Axonics F15™ system?

The Axonics F15™ system offers increased device longevity, constant current stimulation, and a user-friendly remote control.